How not to report about vaccine safety issues, Toronto Star edition

This is the original headline of the Toronto Star‘s scientifically incompetent and fear mongering Gardasil story. It was later changed to “Families seek more transparency on HPV vaccine.”

I remember it well, because several of my readers forwarded it to me not long after it appeared on the website of the Toronto Star: An eye-catching headline proclaiming a “wonder drug’s dark side,” that “wonder drug” being Gardasil, one of two vaccines against the human papilloma virus (HPV) designed to prevent cervical cancer by preventing infection with the HPV virus. The story’s caption blared:

Hundreds of thousands of teen girls in Canada have safely taken Gardasil, a vaccine shown to prevent HPV. But a Star investigation has found that since 2008 at least 60 Canadians have experienced debilitating illnesses after inoculation. Patients and parents say the incidents point to the importance of full disclosure of risks.

There was even a video that would have been right at home on a variety of antivaccine websites, such as Age of Autism, SafeMinds, or VaxTruth:

Indeed, the video above reminded me more than anything else, of a segment from the antivaccine “documentary” that functions as antivaccine propaganda, The Greater Good, which portrays as one of its vaccine “victims” Gabi Swank, a girl whose story is not unlike that of Kaitlyn Armstrong, the teen profiled by the Star. Both girls had a deterioration of their health that appears to have happened sometime after receiving Gardasil. Both attribute their health issues to Gardasil. Neither story was examined with even a modicum of skepticism or critical thinking. In fact, part of the reason I recognized immediately how bad the Star story was derives from my previous experience examining similar stories promoted by the particularly vociferous wing of the antivaccine movement that focuses on the perceived “evils” of Gardasil. That’s something we expect from an antivaccine propaganda film like The Greater Good. We expect better from investigative journalists like David Bruser and Jesse McLean. We don’t get it.

I had meant to blog about this incident because the Star story was such a horrendously bad story from a scientific perspective, but, blogging being what it is, other topics intruded and for some reason I never got back to this topic. Over the last 11 days, however, the criticism and inept responses kept percolating along, as you will see, involving a clueless editor who lashed out at critics, a public editor who just didn’t “get it,” and a newspaper that took far too long to admit that it had screwed up epically and only then after sliming its critics. Fortunately, an excellent analysis in the Los Angeles Times by Michael Hiltzik provided me with an “in” to do the post I had wanted to do before. How the Toronto Star wrote the story is an object lesson in how not to do a vaccine safety story, and how it responded to reasonable criticism was an even more pointed lesson in how not to deal with scientific critics.

Where the Star went wrong

As I read the Star report and then watched the video, I was appalled at how any reputable newspaper could fall into the obvious traps that David Bruser and Jesse McLean clearly stumbled blindly into when they were researching the story. Their first and biggest mistake was to take anecdotes like Kaitlyn Armstrong’s at face value:

By the time Kaitlyn Armstrong received her third and final injection of the popular HPV vaccine Gardasil, pain had spread through the Whitby teen’s body, migrating from her back to her knees to her hips.

After her first dose, Natalie Kenzie of London developed egg-size lumps on the soles of her feet, her joints swelled and her limbs twitched uncontrollably.

Before getting the shots, both 13-year-old girls were told the vaccine had no significant risks. And as they struggled to learn what ailed them, and began to believe Gardasil played a role, doctors dismissed their concerns.

And:

Kaitlyn Armstrong said she and her fellow eighth graders heard about Gardasil from a guidance counsellor during a short information session given at her Whitby school in September or October of 2009.

“She told us it was going to protect us from cervical cancer, it’s a really good idea to get it. She was pushing it. She didn’t talk about any complications or any of that stuff,” recalled Armstrong, who is now 17 and wants to be a pediatric nurse. “My grandpa had died a few months before from cancer, so of course I was right on board.”

At the time, Armstrong danced 20 hours a week, played soccer and ran track. After the first Gardasil shot, the pain started in her back. After the second and third shot, it spread to other joints, her knees and hips. Amanda Dubreuil, who taught Kaitlyn at her Oshawa dance studio, remembers what happened next.

“It was one of the saddest things I’ve ever seen. When I first started teaching her, she was so incredibly strong, one of the most physically gifted girls I had seen in a while. Over the course of three months she started deteriorating.”

The video features Armstrong, an articulate and appealing young woman, telling her story, which could not help but evoke sympathy for her. One thing she says that is particularly revealing is that it “took a few weeks after I got the shot” for the pain to begin. This, of course, is the classic fallacy in these stories of confusing correlation with causation. I’d have to have a cold heart indeed not to be moved by her story, and I was as I watched. Here is a formerly vibrant and energetic girl who loved to dance and was good at it. Over the course of a few months, this girl found herself developing chronic pain to the point where she could no longer dance. Her description of how in dance class she could no longer warm up and had to sit in the class watching her friends dance while she could not is heartbreaking. That being said, her story as presented in the Star is not convincing evidence that Gardasil had anything to do with the deterioration in her health.

A quick Googling of Kaitlyn Armstrong’s name plus the word “Gardasil” revealed quite a few articles about her and her problems with chronic pain that she linked to the Gardasil vaccine. For instance, I found a particularly telling statement in this article:

Kaitlyn didn’t know at the time that her suffering would later be linked to the vaccine.

And who linked her suffering to Gardasil? Take a guess:

Finally in March 2012, a naturopathic doctor asked what Kaitlyn’s latest vaccine was. Turns out, Ms. Armstrong says, there is a heavy concentration of aluminum in the vaccine, and Kaitlyn is allergic to metals. She had no clue this was an ingredient — something she always looks for as it’s a long-standing allergy of Kaitlyn’s.

“My body didn’t know how to deal with it,” Kaitlyn says, adding medical tests confirmed the high metal concentration in her blood.

Her mother explained in a presentation to the Durham District School Board that her daughter’s body was blocking her ability to absorb vitamin D and iron, and Kaitlyn’s liver and kidneys were working overtime to rid her body of the metals.

Kaitlyn is now on detox, with weekly appointments at a private clinic downtown Toronto where she receives vitamin pushes through an IV. She also gets her blood cleaned to remove the metals.

So, here we have a story of a girl who had developed puzzling, debilitating chronic pain that doctors were having a hard time diagnosing, again, a very common story for fibromyalgia patients. Then she ended up at a naturopath’s office, and because naturopaths are very commonly antivaccine that naturopath asked about—you guessed it!—vaccines. Gardasil came up, and even though the time between the symptoms and the vaccine was several weeks, the link was made, and “detoxification” treatment prescribed, complete with what sounds like the quackery that is chelation therapy. One wonders if Kaitlyn’s diagnosis of high levels of heavy metals in her blood was based on a provoked urine test for metals. I bet it was. Yes, indeed it was, as this more detailed description of Kaitlyn’s story clearly reveals to anyone familiar with the quackery that is provoked urine testing for heavy metals:

Jump ahead to February while we wait for the MRI, a friend suggests a naturopath. At this point as a concerned parent who feels helpless I figure why not we have nothing to lose. Our appointment with the naturopath enlightens us to the ingredients of the HPV vaccine. Little did I know that it contained an aluminum adjuvant. I felt sick to my stomach hearing this information. Kaitlyn had a pre-existing metal allergy. I was never told the ingredients of the vaccine, nor was I told the scope of individuals that should not receive it. She needed to start the process of detoxing her body, which most people know is a very long slow process.

In the meantime, a nurse friend of mine informed me of a medical doctor who practices natural medicine in downtown Toronto, about 45 minutes from our home. This doctor does a procedure called chelation. So in March 2012 we started seeing Dr. Jaconello and she began weekly vitamin push treatments with him. We have learned that it is believed the vaccine has caused an auto-immune response in her body attacking her joints. This explains the swollen lymph nodes, the yeast infections, the skin rashes and the all over joint pain.

In May, 2012 she started chelation via injections and IVs. To put it into perspective, prior to her first injection, the aluminum level in her urine was 0.10 mg; 6 hours after chelation it was measured again and 210mg came out. Chelation was and is her miracle. She was scheduled for 10 treatments but after only 6 treatments, she is almost back to her old self. The smile has returned to her eyes. She is back to running and playing soccer at the competitive level. She still has pain in her knees, back and hips but it is bearable. It used to always be a 9/10 or a 10/10 today it is a 3 or 4/10. She is about 85% back to her old self. Her strength and agility is returning. She is very determined both mentally and physically.

Yep. That’s the scam of “provoked urine testing.” Of course if you administer a chelator the level of various metals in the urine will increase dramatically, even if there is metal poisoning. That’s what chelating agents do!

I feel very sorry for Kaitlyn Armstrong. I truly do. Not only has she developed a chronic pain syndrome at an age when she should just be concentrating on high school and the dance lessons that she clearly loves, but she’s now been led down the rabbit hole of naturopathic quackery. I’m glad she’s getting better, but you can bet that it almost certainly has nothing to do with anything either the naturopath or Dr. Jaconello has done. Again, the course of fibromyalgia tends to be to wax and wane.

A 14-year-old Quebec girl, Annabelle Morin, died two weeks after receiving the second injection of the vaccine.

It was 7:30 p.m. on the night of Dec. 9, 2008, when her mother, Linda, found her in the tub, her head underwater and turned to the side.

The paramedics lifted Annabelle’s body on to a stretcher. “I put a blanket on her, saying, ‘She’s going to freeze,’ ” Linda recalled. “I did not know she was already dead.”

The Quebec coroner’s office said the cause of death was drowning, yet also said that any role Gardasil might have played should be further investigated.

Then:

From her home in Laval, Que., Linda Morin, 55, recalled the night of her daughter’s drowning, when she returned home from the hospital and was questioned by two police officers. She did not, at the time, have an explanation.

Not until a few months later, when she read an article about two young Spanish girls who suspected Gardasil caused their hospitalizations, did Morin think she might have an answer.

She called her daughter’s school, asked some questions, took some notes and built a timeline.

Annabelle got her first Gardasil shot on Oct. 9, 2008. Morin remembered that on Oct. 25 Annabelle “came out of (her) room disoriented, she could hardly walk, she couldn’t speak. She was mumbling.” Annabelle was also vomiting and complained of a bad headache. Morin took her daughter to the hospital, where a brain scan turned up nothing. Soon Annabelle felt better.

The episode occurred 16 days after her first Gardasil shot.

Annabelle got her second shot on Nov. 24. After about the same span of time, 15 days later, she died.

As tragic as this story is and as much as I feel for the parents, there is no good evidence in this story that Gardasil had anything whatsoever to do with Annabelle’s tragic drowning. Indeed, the story for correlation isn’t even that strong. Annabelle felt ill two weeks after the first shot in the series, which isn’t particularly strong a correlation, particularly given that she got better quickly. Then, two weeks after her second shot, she died. The story is not particularly compelling evidence of causation. In fact, Annabelle’s story sounded familiar; so I did some Googling. It’s been discussed before in great detail by someone very near and dear to me, if you know what I mean. One thing I know now is that Annabelle had a history of migraines, which could have easily explained her first incident of feeling sick and disoriented. The other thing I now remember is that Annabelle’s mother latched onto Gardasil as the cause of her daughter’s death and is suing Merck after apparently having encountered one of Joe Mercola’s fear mongering articles about Gardasil online.

Indeed, Morin’s case has been used by two antivaccine “scientists” (and these days I use the term loosely to describe them), Lucija Tomljenovic and Christopher A. Shaw, who featured Morin’s anecdote in an article in which they attempted to argue that deaths after Gardasil were caused by Gardasil when they almost certainly were not. Despite all these problems with Morin’s story about her daughter, the Star‘s video featured Linda Morin telling her story, looking over video of her daughter riding a horse, completely with manipulatively sad piano music playing over. The video even includes a shot of this poor girl’s sad mother putting flowers on her grave, after which Ms. Morin laments that Annabelle was her only child, over a shot of her daughter’s empty bedroom, complete with a close-up of doorway where her daughter’s height was marked with a pen at various ages from 4 to 9. The video concludes with Ms. Morin saying that we “have to remember Annabelle” and that “she didn’t die for nothing.”

Again, no one could watch that video and fail to be moved by Ms. Morin’s grief, still raw over six years later, but the emotion provoked by the deeply sad spectacle of a mother who unexpectedly lost her daughter washes away all trace of critical thinking. Did these reporters even Google any of these girls’ names? There are blog posts discussing their cases and why they are not convincing evidence linking Gardasil to their deaths or adverse health outcomes. True, they’re buried among a whole lot of antivaccine websites capitalizing on their stories, but surely some critical reporting was warranted.

Misusing VAERS and the Health Canada database

One thing that David Bruser and Jesse McLean did that American reporters frequently do is to misunderstand the purpose of an open adverse event reporting database. In the US, we have the Vaccine Adverse Event Reporting System (VAERS). Designed as a “canary in the coalmine”-type early warning system designed to pick up adverse events early, it’s a database to which anyone can contribute a suspected vaccine adverse event. It is not authoritative, and the adverse events are not generally verified. Indeed, as has been reported before, one pro-vaccine blogger, Dr. Jim Laidler, reported that the influenza vaccine turned him into the Incredible Hulk. True, the VAERS staff did contact this blogger and ask him about it, but, as he noted, if he had refused to remove the entry, it would still be there. Another pro-vaccine blogger, Kevin Leitch, verified that VAERS lets you enter basically anything by reporting that a vaccine had turned his daughter into Wonder Woman. Not surprisingly, antivaccine lawyers have made the database almost worthless as a source of information over the incidence of adverse events due to vaccines by encouraging their clients to enter all sorts of reports, in particular reports claiming that vaccines caused autism.

So what did the Star reporters do? This:

In the U.S., where there is a public database of vaccine-related side-effect reports collected from around the world, the Star found thousands of suspected cases, including more than 100 deaths.

This is exactly how the VAERS database should not be used.

Apparently Health Canada runs a similar database, which the reporters used thusly:

In Canada, when doctors, nurses, pharmacists or patients suspect a pharmaceutical or vaccine has caused a side-effect, they can file a report with Health Canada. The Star analyzed the regulator’s database of reports and found more than 50 “serious” incidents, including at least 15 hospitalizations connected to the vaccine since 2007.

Inclusion of a particular reaction does not necessarily mean that it was caused by the suspected health product(s). Certain reported reactions may occur spontaneously. They provide a background rate in the general population and may have a temporal, but not necessarily a causal, relationship with the health product. The purpose of the Canada Vigilance Program is to detect possible signals of adverse reactions associated with health products. Additional scientific investigations are required to validate signals from the Canada Vigilance Program and to establish a cause and effect relationship between a health product and adverse reaction. Assessment of causality must include other factors such as temporal associations, the possible contribution of concomitant medication or therapies, the underlying disease, and the previous medical history.

So what did Bruser and McLean do with these reports? The same thing they did with the VAERS reports, they misinterpreted them to provoke maximal fear of Gardasil:

Suspected side-effects listed in the Canadian reports include: Convulsions; more than 10 cases of joint, abdominal and other serious pain; two cases of anaphylaxis, a severe allergic reaction; two deaths, including that of a 10-year-old girl; and a hemorrhage, stroke and life-threatening heart condition. In many of the cases, the patients were teenagers, often 13 or 14 years old.

Yes, they did qualify their statements by stating that these reactions were not necessarily due to the vaccine, but in the context of video of a mother laying flowers on the grave of her dead daughter and teen dancer lamenting how she can’t dance anymore because of Gardasil, this disclaimer doesn’t carry much force. Overall, this Star report is one of the most irresponsible stories about vaccines I’ve ever seen, and that’s saying a lot.

Criticism, backlash, and capitulation

Not surprisingly, bloggers who are proponents of evidence- and science-based medicine pounced on the Star‘s story as the crap journalism that it was. Jen Gunter, for instance, was an early and vocal critic, and our very own Scott Gavura also weighed in, characterizing the Star‘s article as a “gift to the antivaccine movement.”. Quite correctly, Dr. Gunter pointed out that the authors had confused correlation with causation and cited:

A 2013 study of almost a million girls finding no increased risk of autoimmune disorders, neurological illnesses or blood clots (answering one questioned raised in the Star article).

A 2014 study finding no increased incidence of autoimmune disorders after Gardasil.

A detailed review of the VAERS data from 2009 that concluded that most of “the AEFI rates were not greater than the background rates compared with other vaccines, but there was disproportional reporting of syncope and venous thromboembolic events. The significance of these findings must be tempered with the limitations (possible underreporting) of a passive reporting system.” In other words, there was no obvious link.

Dr. Gunter was also very critical of how the authors credulously interviewed Dr. Diane Harper. As am I. Look at how the Star reported it:

“It’s very sad because what I see is the physicians are not accepting the fact that these young women have pain and issues,” said Dr. Diane Harper, who was the principal investigator of a major clinical trial for Merck as the company was developing the blockbuster vaccine for the worldwide market. “The docs in the trenches have been conditioned to respond, ‘vaccines don’t have side-effects.’ ”

Harper, now the chair of family and geriatric medicine at the University of Louisville in Kentucky, said Gardasil’s approval by the FDA was fast-tracked unnecessarily, since the progression of an HPV infection to cancer often takes decades and can be detected through regular pap screens. She said the vaccine could have been analyzed over a much longer time frame.

“There could be harm,” Harper said. “You just don’t know until you look at it in the full population.”

It wasn’t too long before the Star‘s ill-advised counterattack began. In response to all the criticism, Star columnist Heather Mallick wrote an op-ed entitled “Vaccine debate is one we shouldn’t even be having“, in which she lashed out at critics of the Star story, in particular Dr. Gunter, whom she dismissed and disparaged thusly:

Here’s a tip: don’t read a website run by a rural doctor whose slogan is “wielding the lasso of truth.”

One wonders what Mallick has against “rural” doctors that she would use the term as an insult. In any case, she doubled down on the Star’s story, framing it thusly:

The Gardasil vaccine story reported Thursday by David Bruser and Jesse McLean of the Toronto Star was about information, and access to it. It was not about the drug itself — it is safe and effective — but about parents and girls not always being told what they need to know in order to make informed decisions, and being dismissed by doctors when they became terribly ill.

The problem, of course, is that girls are given information about adverse reactions. Just because an adverse reaction is reported in the VAERS or Health Canada database does not mean that the vaccine caused the reaction, as Dr. Gunter retorted and I just explained in detail above.

Mallick then made this analogy:

You’re either for vaccinations or against them, never mind the grey areas. This is Tea Party thinking, to react with alarm rather than reason. It has brought us mandatory sentencing, anti-choice clinics that lure young pregnant women, climate-change deniers and men’s rights. It is a fact-free zone, and when it intersects with Canadian life, it makes it much more difficult to make rational decisions.

And the vaccine debate is one we shouldn’t even be having. The loony American right’s obsession with non-science, in the face of all the facts, should not spill over into Canada.

Which is a complete straw man. The Star endured criticism not because the “loony American right’s obsession with non-science” had spilled over into Canada but because two Star reporters had royally screwed up, and the editors failed to recognize how bad the screw-up was! It had absolutely nothing to do with politics. Particularly amusing, though, was how Mallick tried to invoke Ben Goldacre’s name and his new book to justify her position. Goldacre, in response, let loose with an epic and entertaining series of Tweets that should be required reading for anyone who wants to know how to do a Twitter smackdown correctly. Seriously. You should stop right here, click that link, and scroll down to Goldacre’s Tweets. They eviscerate Mallick’s nonsense in the way her nonsense needed to be eviscerated. Here’s a taste:

Over the weekend, and again on Monday morning, I wrote to the Toronto Star about my concerns. The editor-in-chief Michael Cooke replied first. He dismissed the questions I raised, and pointed to a “very pro-Gardasil story” I wrote for Vox recently. He then said that my “time might be better spent doing your own Vox-paid-for research into Gardasil-good-and-questionable rather than idly picking into other reporters’ work” and that I should “stop gargling our bathwater and take the energy to run yourself your own, fresh tub.” He’s a charmer.

Indeed. There’s nothing like attacking civil and reasonable critics with the pharma shill gambit and accusing them of laziness.

It also turns out that the public editor Kathy English was singularly ineffective. She appeared not to focus on the disclaimer that “there is no conclusive evidence showing the vaccine caused a death or illness” and ignore the overall impression that the stories of a teenage girl who died suddenly and another one suffering from chronic debilitating pain produce, which, given how they were told, completely overwhelmed the nuance of that disclaimer. She also responded, “The story was not intended to be either anti-vaccine nor pro-vaccine.” As Julia Belluz correctly noted, that’s not how readers will see it, given how little the Star did to contextualize their finding.

Over the course of the week, the criticism became too much, and it became so apparent that the Star had made the most epic of epic fails, that the Star‘s backing it up and seeking a way out of the mess it had created for itself became inevitable. I’m just surprised it took the Star so long. First, on Wednesday the Star published an article entitled “Science shows the HPV vaccine has no dark side“, featuring signatures of 65 specialists. One wonders why the Star apparently never consulted any of them in its original story. Then the title of the original article, as noted, was changed from “A Wonder Drug’s Dark Side” to “Families seek more transparency on HPV vaccine.”

The correction, it’s hard not to note, did not run on the front page, where the original story first ran, as Julia Belluz noted sarcastically on Twitter:

So @TorStarEditor runs Gardasil corrective on A17. A step in right direction, but needed to be A1. Before “50 shades” review & “satanic cat”

Finally, the Star‘s publisher, John Cruickshank, was forced to apologize, saying we failed in this case, which is the understatement of the year thus far. It’s too little and too late, particularly after Cruickshank’s staff had so unprofessionally lashed out at critics. Coming around full circle, as Michael Hiltzik noted in his excellent Los Angeles Times commentary:

The article implied that hundreds of thousands of Canadian families had been systematically misled about Gardasil’s supposed dangers by doctors, the pharmaceutical industry and Canadian public health officials. Interspersed among its emotion-laden anecdotes were acknowledgments that years of scientific studies have shown no linkage between Gardasil and such symptoms. These included a study financed by the governments of Sweden and Denmark of 998,000 Swedish and Danish girls ages 10-17, of whom 297,000 had received at least one dose of the vaccine. The study, which found “no consistent evidence for a plausible association” between the vaccine and serious disorders, matched results from other studies involving hundreds of thousands of subjects.

But as the Star’s publisher later conceded, the “you-are-there” depiction of families struggling with illness and death hopelessly overwhelmed its acknowledgments of Gardasil’s established safety and efficacy.

Exactly.

We humans, as I’ve said many times before, are pattern-forming animals. We are very quick to confuse correlation with causation, and our memories are malleable. We also desperately crave explanation. Linda Morin suffered a horrific unexpected loss; it’s natural that she would seek explanation. It’s human that she would latch onto what is almost certainly the wrong explanation for her daughter’s death. It’s what humans do. The same is true for Kaitlyn Armstrong and her family. Kaitlyn developed a puzzling and little-understood condition at a very young age. Naturally her mother wanted an explanation. Unfortunately, her search for an explanation led her and her daughter straight into the arms of a naturopath quack, who is blaming her illness on the aluminum adjuvant in the vaccine and treating it with chelation therapy and intravenous vitamins.

As for readers, because we humans are social animals who want to believe the accounts our fellow humans relate to us, particularly when those fellow humans are as sympathetic as, for example, the grieving mother of a dead teen girl, to the average reader sympathetic anecdotes will almost always trump dry scientific evidence that tells us that Linda Morin’s grief and Kaitlyn Armstrong’s suffering are almost certainly not due to Gardasil, particularly when the grieving mother is shown laying flowers on her daughter’s grave with sad music accompanying it in a video. Reporters know this. Editors know this. Publishers know this. Why is the leadership of the Toronto Star so surprised that the Star‘s story provoked the harsh criticism that it did?

Probably because they really did think they were on to something. More’s the pity. I can only hope that they learned something from this journalistic debacle, but I fear they probably didn’t.